The following data is part of a premarket notification filed by Orthopro Llc with the FDA for Orthopro Steinman Pins And Kirschner Wires.
Device ID | K070555 |
510k Number | K070555 |
Device Name: | ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES |
Classification | Pin, Fixation, Smooth |
Applicant | ORTHOPRO LLC 13115 NE 4TH ST., SUITE 130 Vancouver, WA 98684 |
Contact | Christopher Cook |
Correspondent | Christopher Cook ORTHOPRO LLC 13115 NE 4TH ST., SUITE 130 Vancouver, WA 98684 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-02-27 |
Decision Date | 2007-07-13 |
Summary: | summary |